Regulatory: Page 134

Navidea fails to get clearance for Lymphoseek
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration has elected not to approve radiopharmaceutical developer Navidea Biopharmaceuticals' new drug application for its Lymphoseek radiopharmaceutical.
September 10, 2012
A rocky road awaits radiologists during Obamacare rollout
By James Brice
SAN FRANCISCO - Higher taxes, lower reimbursement, and more federal control over the use of advanced imaging in clinical practice. Dr. Frank J. Lexa used these terms to describe a dark vision of radiology after healthcare reform at the 2012 California Radiological Society annual meeting.
September 10, 2012
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UPMC, staffing agencies sued in Kwiatkowski case
By AuntMinnie.com staff writers
UPMC health system and two medical staffing agencies have been sued by a Kansas woman who claims she was infected with hepatitis C because the defendants failed to notify authorities that traveling radiologic technologist David Kwiatkowski had been fired in 2008 for allegedly stealing drugs from the hospital.
September 9, 2012
FDA calls out Lilly on Amyvid images
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration is admonishing Eli Lilly for posting what it called "misleading" multicolored images on its website illustrating results with the PET radiopharmaceutical Amyvid (florbetapir F-18 injection).
September 9, 2012
ASTRO asks CMS to halt planned payment cuts
By AuntMinnie.com staff writers
A letter to the U.S. Centers for Medicare and Medicaid Services (CMS) is the American Society for Radiation Oncology's (ASTRO) latest push in its campaign to stop proposed payment cuts of nearly $300 million scheduled to begin next near.
September 9, 2012
Merge eyes strategic options, hit with FDA warning letter
By Erik L. Ridley
Healthcare IT and advanced visualization developer Merge Healthcare has retained investment bank Allen & Company to assist the firm in evaluating a broad range of strategic alternatives, including a sale of the company or a business combination.
September 5, 2012
ICSA Labs to authorize EHRs
By AuntMinnie.com staff writers
ICSA Labs, a division of Verizon, has received authorization from the U.S. Department of Health and Human Services to certify electronic health records (EHRs) for the next stage of meaningful use requirements.
September 5, 2012
IMRIS wins patent, FDA clearance
By AuntMinnie.com staff writers
Image-guided therapy developer IMRIS said it has been granted a U.S. patent for MR-guided radiation therapy, which involves the combination of radiation therapy and a moveable magnet system.
September 4, 2012
International Isotopes gets NRC approval
By AuntMinnie.com staff writers
Radioisotope manufacturer International Isotopes has received U.S. Nuclear Regulatory Commission (NRC) approval of the final environmental impact statement for its planned depleted uranium deconversion and fluorine extraction processing facility.
September 3, 2012
Siemens releases Multix Fusion DR in U.S.
By AuntMinnie.com staff writers
Siemens Healthcare has received U.S. Food and Drug Administration 510(k) clearance for its Multix Fusion digital radiography (DR) system.
September 3, 2012
Imaging use in Medicare is down, but will the feds take heed?
By Kate Madden Yee
Medicare payments for noninvasive diagnostic imaging exams are down 21% compared with their peak in 2006, reports a new study in the September issue of the Journal of the American College of Radiology. But are federal policymakers paying attention?
September 3, 2012
Calif. Legislature passes 2nd breast density bill
By AuntMinnie.com staff writers
In another attempt at passing breast density notification legislation, the California State Senate and Assembly have passed a bill that would require women with dense breast tissue to be informed of their status.
August 29, 2012
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